Urinary Incontinence, StressNCT05570071
A Study of the Use of Vaginal Radiofrequency Therapy in Treatment of SUI.
A study testing physical therapy in people with Urinary Incontinence, Stress, run by Qianfoshan Hospital.
Trial summary
To investigate the immediate, short-term and long-term efficacy of vaginal radiofrequency therapy in the treatment of stress urinary incontinence, and to compare the efficacy of pelvic floor electromyography combined with biofeedback therapy in stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2022to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old women with a sexual history, and patients with mild to moderate stress urinary incontinence.
Who cannot join
- Severe cardiopulmonary insufficiency, acute pelvic inflammatory disease or other infectious stage, non-steroidal anti-inflammatory drugs and steroid hormones affecting collagen production factors, POP-Q-2 and above prolapse.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Clinical Study of the Use of Vaginal Radiofrequency Therapy in Treatment of Stress Urinary Incontinence.
To investigate the immediate, short-term and long-term efficacy of vaginal radiofrequency therapy in the treatment of stress urinary incontinence, and to compare the efficacy of pelvic floor electromyography combined with biofeedback therapy in stress urinary incontinence.
Read the detailed description
Before treatment, patients with mild and moderate stress urinary incontinence were diagnosed according to the diagnostic criteria through medical history inquiry and gynecological physical examination, and patients were screened according to the inclusion and exclusion criteria. After informing two treatment plans and signing the informed consent, they were randomly divided into vaginal radiofrequency therapy group and electrical stimulation combined biofeedback group. After being included in the test, one hour urine pad test was conducted, and IIQ-7, PISQ-12 and FSFI questionnaires were completed. IIQ-7, PISQ-12 and FSFI questionnaires were followed up 1, 3, 6 and 12 months after treatment. After 3 months and 1 year of treatment, 1 hour urine pad test was given again.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- physical therapy
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapyDevice
medical treatment of pelvic floor
| Study group | Role | What they receive |
|---|---|---|
| vaginal radiofrequency | Experimental | vaginal radiofrequency therapy 4 times Receives: Device: physical therapy |
| electromyography biofeedback | Active comparator | electromyography combined with biofeedback therapy 15 times Receives: Device: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine leakage in 1-hour pad test
measure the urine leakage in 1-hour pad test
Measured: before therapy
Change from urine leakage at 3 months
measure the urine leakage in 1-hour pad test at 3 months
Measured: 3months after therapy
Change from urine leakage at 12 months
measure the urine leakage in 1-hour pad test at 12 months
Measured: 12months after therapy
Secondary outcomes (9)
incontinence impact questionnaire short form,IIQ-7
Urinary incontinence may affect daily activities, interpersonal relationships or personal emotions.The minimum value is 0,and the maximum value is 21. Higher scores mean a worse outcome.
Measured: before therapy
incontinence impact questionnaire short form,IIQ-7
Urinary incontinence may affect daily activities, interpersonal relationships or personal emotions.The minimum value is 0,and the maximum value is 21. Higher scores mean a worse outcome.
Measured: 3months after therapy
incontinence impact questionnaire short form,IIQ-7
Urinary incontinence may affect daily activities, interpersonal relationships or personal emotions.The minimum value is 0,and the maximum value is 21. Higher scores mean a worse outcome.
Measured: 12months after therapy
pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12
The sexual desire，orgasm，pain，urine leakage in sex of the participants.The minimum value is 0,and the maximum value is 48.Higher scores mean a better outcome.
Measured: before therapy
pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12
The sexual desire，orgasm，pain，urine leakage in sex of the participants.The minimum value is 0,and the maximum value is 48.Higher scores mean a better outcome.
Measured: 3months after therapy
pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12
The sexual desire，orgasm，pain，urine leakage in sex of the participants.The minimum value is 0,and the maximum value is 48.Higher scores mean a better outcome.
Measured: 12months after therapy
Female Sexual index，FSFI
Sex frequency，sexual satisfaction, physiological factors, affective factor , sexual partner factor. The minimum value is 0,and the maximum value is 124.Higher scores mean a better outcome.
Measured: before therapy
Female Sexual index，FSFI
Sex frequency，sexual satisfaction, physiological factors, affective factor , sexual partner factor. The minimum value is 0,and the maximum value is 124.Higher scores mean a better outcome.
Measured: 3months after therapy
Female Sexual index，FSFI
Sex frequency，sexual satisfaction, physiological factors, affective factor , sexual partner factor.The minimum value is 0,and the maximum value is 124. Higher scores mean a better outcome.
Measured: 12months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start20 Oct 2022 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Yan, Qianfoshan Hospital
- Investigators
- Li Yan, Study director, Shandong First Medical UniversityMiao Yuan, Principal investigator, Shandong First Medical UniversityFangfang Zhao, Principal investigator, Shandong First Medical UniversityGuangli Liu, Principal investigator, Shandong First Medical UniversityJing Li, Principal investigator, Shandong First Medical UniversityMin Lu, Principal investigator, Shandong First Medical UniversityHongyan Niu, Principal investigator, Shandong First Medical UniversityDongyue Wang, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570071
- Sponsor's protocol ID
- 2022001
- Status last verified
- Oct 2022
- First submitted
- 26 Sep 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Study of the Use of Vaginal Radiofrequency Therapy in Treatment of Stress Urinary Incontinence.
- ClinicalTrials.gov ID
- NCT05570071
- Acronym / sponsor ID
- 2022001
- Conditions
- Urinary Incontinence, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 20 Oct 2022 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the immediate, short-term and long-term efficacy of vaginal radiofrequency therapy in the treatment of stress urinary incontinence, and to compare the efficacy of pelvic floor electromyography combined with biofeedback therapy in stress urinary incontinence.
Detailed description
Before treatment, patients with mild and moderate stress urinary incontinence were diagnosed according to the diagnostic criteria through medical history inquiry and gynecological physical examination, and patients were screened according to the inclusion and exclusion criteria. After informing two treatment plans and signing the informed consent, they were randomly divided into vaginal radiofrequency therapy group and electrical stimulation combined biofeedback group. After being included in the test, one hour urine pad test was conducted, and IIQ-7, PISQ-12 and FSFI questionnaires were completed. IIQ-7, PISQ-12 and FSFI questionnaires were followed up 1, 3, 6 and 12 months after treatment. After 3 months and 1 year of treatment, 1 hour urine pad test was given again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaginal radiofrequency | Experimental | Device: physical therapyvaginal radiofrequency therapy 4 times |
| electromyography biofeedback | Active comparator | Device: physical therapyelectromyography combined with biofeedback therapy 15 times |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-75 years old women with a sexual history, and patients with mild to moderate stress urinary incontinence.
Key exclusion criteria (1 listed)
- Severe cardiopulmonary insufficiency, acute pelvic inflammatory disease or other infectious stage, non-steroidal anti-inflammatory drugs and steroid hormones affecting collagen production factors, POP-Q-2 and above prolapse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical therapymedical treatment of pelvic floor | Device | electromyography biofeedback, vaginal radiofrequency |
Primary outcome
Urine leakage in 1-hour pad test
Time frame: before therapy
measure the urine leakage in 1-hour pad test
Change from urine leakage at 3 months
Time frame: 3months after therapy
measure the urine leakage in 1-hour pad test at 3 months
Change from urine leakage at 12 months
Time frame: 12months after therapy
measure the urine leakage in 1-hour pad test at 12 months
9 secondary outcomes
incontinence impact questionnaire short form,IIQ-7
Time frame: before therapy
incontinence impact questionnaire short form,IIQ-7
Time frame: 3months after therapy
incontinence impact questionnaire short form,IIQ-7
Time frame: 12months after therapy
pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12
Time frame: before therapy
pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12
Time frame: 3months after therapy
pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12
Time frame: 12months after therapy
Female Sexual index，FSFI
Time frame: before therapy
Female Sexual index，FSFI
Time frame: 3months after therapy
Female Sexual index，FSFI
Time frame: 12months after therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Yan study director
Shandong First Medical University
Miao Yuan principal investigator
Shandong First Medical University
Fangfang Zhao principal investigator
Shandong First Medical University
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy in people with Urinary Incontinence, Stress, run by Qianfoshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yan (+860531-89268917, yanliqy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine leakage in 1-hour pad test (time frame: before therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.